RecruitingNot ApplicableNCT07142967

Trial Evaluating the Safety and Efficacy Of MR-Linac-Guided Radiotherapy as Salvage Treatment After External Beam Radiotherapy Recurrence (TUMORNATOR II)


Sponsor

NYU Langone Health

Enrollment

28 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the impact of prostate-specific membrane antigen/positron emission tomography (PSMA/PET)-informed magnetic resonance (MR)-guided radiation therapy on serious toxicity outcomes in patients with biopsy-proven locally radiorecurrent prostate cancer. The primary aim is to evaluate the safety of delivering MR-Linac-guided stereotactic body radiotherapy (SBRT) after prior prostate external beam radiotherapy for recurrent disease, and assess urinary toxicity outcomes at 2 years.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized type of radiation treatment that uses a combination of MRI imaging and a radiation delivery machine (MR-Linac) to precisely target a recurrence of prostate cancer in men whose cancer came back after prior external beam radiation therapy. **You may be eligible if...** - You are a man aged 18 or older - You have prostate cancer that came back after prior radiation therapy, confirmed by biopsy - Your testosterone level is adequate (50 ng/dL or higher) - Your prostate size, urinary symptoms, and general health status meet study requirements - Your tumor is visible on MRI - Your cancer has not spread outside the prostate on scans **You may NOT be eligible if...** - You have previously had prostate brachytherapy (internal radiation seeds) - You are currently receiving hormone-blocking therapy - Your cancer has spread outside the prostate or to lymph nodes - You have Crohn's disease or ulcerative colitis - You have a pacemaker, severe claustrophobia, or cannot tolerate an MRI - Your disease-free period after initial radiation was less than 2 years - You have had a TURP (prostate scraping procedure) within the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Body Radiation Therapy (SBRT)

SBRT will be delivered with a prescription dose of 8 Gy x 5 fractions prescribed to the 95% isodose line encompassing the dominant recurrent intraprostatic lesion (DRIL) as seen on MRI and/or PET PSMA imaging plus 4mm (GTV+4mm=CTV\_40). Remainder of the prostate gland minus CTV\_40 (CTV\_25) will be prescribed to 5 Gy x 5 fractions at the 95% isodose line.

DRUGAndrogen Deprivation Therapy (ADT)

ADT would be given 0-1 months prior to planned SBRT to the prostate for total of 4-6 months. ADT will be administered via Leuprolide or Degarelix monthly injections or daily Relugolix pills.


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT07142967